Multicenter Postapproval Clinical Trial of Integra® Dermal Regeneration Template for Burn Treatment

Abstract

The safety and effectiveness of Integra Dermal Regeneration Template was evaluated in a postapproval study involving 216 burn injury patients who were treated at 13 burn care facilities in the United States. The mean total body surface area burned was 36.5% (range, 1-95%). Integra was applied to fresh, clean, surgically excised burn wounds. Within 2 to 3 weeks, the dermal layer regenerated, and a thin epidermal autograft was placed. The incidence of invasive infection at Integra-treated sites was 3.1% (95% confidence interval, 2.0-4.5%) and that of superficial infection 13.2% (95% confidence interval, 11.0-15.7%). Mean take rate of Integra was 76.2%; the median take rate was 95%. The mean take rate of epidermal autograft was 87.7%; the median take rate was 98%. This postapproval study further supports the conclusion that Integra is a safe and effective treatment modality in the hands of properly trained clinicians under conditions of routine clinical use at burn centers.

The positive effect of negative pressure: vacuum-assisted fixation of Integra artificial skin for reconstructive surgery

“…In our study, grafting was usually scheduled 3 weeks after implantation as recommended by the manufacturer and some authors [10][11][12]. From clinical judgment, and in contrast to some reports [5,7], we did not find any evidence that VAC application significantly accelerated vascularization of Integra so as to allow earlier grafting.…”

“…The major complications leading to partial loss of Integra (infection, nonintegration of the product) as well as seroma formation should rather be seen in the context of the well-known problems specifically related to the application of Integra [5,10,11].…”

A Short Commentary about Efficacy of an Flowable Matrix in the Treatment of Diabetic Foot Ulcers

“…Integra Flowable Wound Matrix (FWM) consists of a lyophilized product derived from Integra Dermal Regeneration Template, a dermal substitute in sheet form [33]. The FWM, consisting of cross-linked type I collagen, in presence of glycosaminoglycans represented by the chondroitin-6-sulfate, provides resorbable three-dimensional scaffold with a high microporosity which allows a migration of cells in the matrix and its remodeling.…”

Innovative Wundtherapie und Hautersatz bei Verbrennungen

“…Die Matrix wird vaskularisiert und durch körpereigenes Kollagen umgebaut. Zu den Indikationen zählt der Dermisersatz nach Débridement tief zweitgradiger und drittgradiger Verbrennungswunden sowie nach flächiger Exzision zur Narbenkorrektur [15]. Nach 3 Wochen ist die Matrix vaskularisiert und nach dem Desilikonisieren können dünne, skarifizierte Spalthaut-Sheets aufgebracht werden.…”